A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of HLX22 Monoclonal Antibody Injection (HER2 Monoclonal Antibody) in Patients With Advanced Solid Tumours Overexpressing HER2
Overview
- Phase
- Phase 1
- Intervention
- HLX22
- Conditions
- Solid Tumor
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose (MTD) of HLX22 in patients with advanced solid tumors overexpressing HER2
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX22 in patients with advanced solid tumors overexpressing HER2 after failure of standard of care.
Detailed Description
This study is an open-label and dose escalation study aimed at exploring the safety and MTD of HLX22. three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign doses to the patients, and thereby determine the MTD of HLX22.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with child-bearing potential must agree to and be able to use effective contraceptive measures.
- •At least 28 days from prior major surgery, prior cytotoxic chemotherapy, prior hormonal therapy (except for androgen-deprivation therapy in patients with prostate cancer), prior therapy with investigational products (or medical device) or local radiotherapy, at least 42 days from prior chemotherapy with nitrosoureas or mitomycin C, and at least 42 days from prior immunotherapy before the first dose of HLX
- •At least one bi-dimensionally measurable lesion to be used as the basis for evaluation.
- •ECOG performance status of ≤ 1 at study entry. Patients with histologically-proven HER2-positive advanced or metastatic solid tumours who are either non-responsive or intolerant to standard therapies.
- •HER2-positive tumours that are confirmed by immunohistochemistry (IHC) and:
- •HER2 mutation of at least 3+ (+++) or
- •HER2 mutation of at least 2+ (++) and fluorescence in situ hybridization (FISH) test positive.
- •Adequate haematologic functions Adequate hepatic functions Adequate renal functions Adequate cardiac functions For patients with hepatocellular carcinoma, Child-Pugh score has to be A. Able to receive treatment and examinations as required by the study protocol. Life expectancy \> 3 months. Exclusion Criteria Patients with history of alcohol or drug abuse, or positive for alcohol breath test before dosing.
- •Patients who still have ≥ Grade 2 toxicities from prior therapies (except for Grade 2 alopecia).
- •Concurrent unstable or uncontrolled medical conditions with either of the following:
Exclusion Criteria
- Not provided
Arms & Interventions
HLX22 group
HLX22, at four dose levels (3, 10, 25mg/kg), to be intravenously injected once every three weeks; Study drugs given until disease progression, one year of treatment, withdrawal from the study or death
Intervention: HLX22
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) of HLX22 in patients with advanced solid tumors overexpressing HER2
Time Frame: from day1 to day 42(cycle 1 and cycle2 ,each cycle is 21days)
The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).
Secondary Outcomes
- the pharmacokinetic characteristics of HLX22 at different doses in patients.(cycle1 to cycle 8 ,and 28-day follow-up visit after the last infusion (if possible),(each cycle is 21 days).)
- the pharmacodynamic characteristics of HLX22 at different doses in patients(cycle 1 to cycle 6 (each cycle is 21 days))
- the immunogenicity of HLX22 in humans(cycle 1 to cycle 6 (each cycle is 21 days))